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Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00739310
First received: August 20, 2008
Last updated: August 24, 2015
Last verified: August 2015
Results First Received: April 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cerebral Palsy
Intervention: Device: Vest Treatment (high frequency chest wall oscillation)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vest Treatment (HFCWO)

Patients will receive Vest treatments for airway clearance therapy 2 x daily

Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes


Participant Flow:   Overall Study
    Vest Treatment (HFCWO)
STARTED   29 
COMPLETED   22 
NOT COMPLETED   7 
Poor adherance to prescribed therapy                4 
Withdrawal by Subject                1 
Lost to Follow-up                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who completed 12 months of prospective therapy

Reporting Groups
  Description
Vest Treatment (HFCWO)

Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.

Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes


Baseline Measures
   Vest Treatment (HFCWO) 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.55  (5.57) 
Gender 
[Units: Participants]
 
Female   8 
Male   14 


  Outcome Measures

1.  Primary:   Hospitalizations Lasting at Least 24 Hours in This Patient Population   [ Time Frame: end of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study design was sub-optimal due to lack of control group and lack of randomization


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathryn Fitzgerald, NP
Organization: Maimonides, Department of Pulmonary Medicine
phone: 718-283-7339
e-mail: kfitzgerald@maimonidesmed.org



Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00739310     History of Changes
Other Study ID Numbers: CR-0088
Study First Received: August 20, 2008
Results First Received: April 20, 2015
Last Updated: August 24, 2015
Health Authority: United States: Institutional Review Board